1-1 By: Averitt (Senate Sponsor - Sibley) H.B. No. 2061 1-2 (In the Senate - Received from the House April 23, 1999; 1-3 April 26, 1999, read first time and referred to Committee on 1-4 Economic Development; May 5, 1999, reported adversely, with 1-5 favorable Committee Substitute by the following vote: Yeas 5, Nays 1-6 0; May 5, 1999, sent to printer.) 1-7 COMMITTEE SUBSTITUTE FOR H.B. No. 2061 By: Sibley 1-8 A BILL TO BE ENTITLED 1-9 AN ACT 1-10 relating to coverage by a health benefit plan of certain 1-11 prescription drugs. 1-12 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: 1-13 SECTION 1. Subchapter E, Chapter 21, Insurance Code, is 1-14 amended by adding Article 21.53M to read as follows: 1-15 Art. 21.53M. COVERAGE FOR OFF-LABEL DRUG USE 1-16 Sec. 1. DEFINITIONS. In this article: 1-17 (1) "Contraindication" means the potential for, or the 1-18 occurrence of, an undesirable alteration of the therapeutic effect 1-19 of a prescribed drug prescription because of the presence, in the 1-20 patient for whom it is prescribed, of a disease condition, or the 1-21 potential for, or the occurrence of, a clinically significant 1-22 adverse effect of the drug on the patient's disease condition. 1-23 (2) "Drug" has the meaning assigned by Section 5, 1-24 Texas Pharmacy Act (Article 4542a-1, Vernon's Texas Civil 1-25 Statutes). 1-26 (3) "Health benefit plan" means a plan described by 1-27 Section 2 of this article. 1-28 (4) "Indication" means any symptom, cause, or 1-29 occurrence in a disease that points out the cause, diagnosis, 1-30 course of treatment, or prognosis of the disease. 1-31 (5) "Peer-reviewed medical literature" means published 1-32 scientific studies in any peer-reviewed national professional 1-33 journal. 1-34 Sec. 2. SCOPE OF ARTICLE. (a) This article applies only to 1-35 a health benefit plan that provides benefits for medical or 1-36 surgical expenses incurred as a result of a health condition, 1-37 accident, or sickness, including an individual, group, blanket, or 1-38 franchise insurance policy or insurance agreement, a group hospital 1-39 service contract, or an individual or group evidence of coverage or 1-40 similar coverage document that is offered by: 1-41 (1) an insurance company; 1-42 (2) a group hospital service corporation operating 1-43 under Chapter 20 of this code; 1-44 (3) a fraternal benefit society operating under 1-45 Chapter 10 of this code; 1-46 (4) a stipulated premium insurance company operating 1-47 under Chapter 22 of this code; 1-48 (5) a reciprocal exchange operating under Chapter 19 1-49 of this code; 1-50 (6) a health maintenance organization operating under 1-51 the Texas Health Maintenance Organization Act (Chapter 20A, 1-52 Vernon's Texas Insurance Code); 1-53 (7) a multiple employer welfare arrangement that holds 1-54 a certificate of authority under Article 3.95-2 of this code; or 1-55 (8) an approved nonprofit health corporation that 1-56 holds a certificate of authority issued by the commissioner under 1-57 Article 21.52F of this code. 1-58 (b) This article does not apply to: 1-59 (1) a plan that provides coverage: 1-60 (A) only for a specified disease or other 1-61 limited benefit; 1-62 (B) only for accidental death or dismemberment; 1-63 (C) for wages or payments in lieu of wages for a 1-64 period during which an employee is absent from work because of 2-1 sickness or injury; 2-2 (D) as a supplement to liability insurance; 2-3 (E) for credit insurance; 2-4 (F) only for dental or vision care; 2-5 (G) only for hospital expenses; or 2-6 (H) only for indemnity for hospital confinement; 2-7 (2) a small employer health benefit plan written under 2-8 Chapter 26 of this code; 2-9 (3) a Medicare supplemental policy as defined by 2-10 Section 1882(g)(1), Social Security Act (42 U.S.C. Section 1395ss), 2-11 as amended; 2-12 (4) workers' compensation insurance coverage; 2-13 (5) medical payment insurance coverage issued as part 2-14 of a motor vehicle insurance policy; or 2-15 (6) a long-term care policy, including a nursing home 2-16 fixed indemnity policy, unless the commissioner determines that the 2-17 policy provides benefit coverage so comprehensive that the policy 2-18 is a health benefit plan as described by Subsection (a) of this 2-19 section. 2-20 Sec. 3. MINIMUM STANDARDS OF COVERAGE. (a) A health 2-21 benefit plan that provides coverage for drugs must provide coverage 2-22 for any drug prescribed to treat an enrollee for a covered chronic, 2-23 disabling, or life-threatening illness if the drug: 2-24 (1) has been approved by the Food and Drug 2-25 Administration for at least one indication; and 2-26 (2) is recognized for treatment of the indication for 2-27 which the drug is prescribed in: 2-28 (A) a prescription drug reference compendium 2-29 approved by the commissioner for the purpose of this article; or 2-30 (B) substantially accepted peer-reviewed medical 2-31 literature. 2-32 (b) Coverage of a drug required by this section shall 2-33 include coverage of medically necessary services associated with 2-34 the administration of the drug. 2-35 (c) A drug use that is covered under this section may not be 2-36 denied based on a "medical necessity" requirement except for 2-37 reasons that are unrelated to the legal status of the drug use. 2-38 (d) This section does not require coverage for: 2-39 (1) experimental drugs not otherwise approved for any 2-40 indication by the Food and Drug Administration; or 2-41 (2) any disease or condition that is excluded from 2-42 coverage under the plan. 2-43 (e) A health benefit plan is not required to cover a drug 2-44 the Food and Drug Administration has determined to be 2-45 contraindicated for treatment of the current indication. 2-46 Sec. 4. RULES. The commissioner may adopt rules to 2-47 implement this article. 2-48 SECTION 2. This Act takes effect September 1, 1999,and 2-49 applies only to a health benefit plan that is delivered, issued for 2-50 delivery, or renewed on or after January 1, 2000. A health benefit 2-51 plan that is delivered, issued for delivery, or renewed before 2-52 January 1, 2000, is governed by the law as it existed immediately 2-53 before the effective date of this Act, and that law is continued in 2-54 effect for that purpose. 2-55 SECTION 3. The importance of this legislation and the 2-56 crowded condition of the calendars in both houses create an 2-57 emergency and an imperative public necessity that the 2-58 constitutional rule requiring bills to be read on three several 2-59 days in each house be suspended, and this rule is hereby suspended. 2-60 * * * * *